BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6273468 · Received January 24, 2017

    Report

    Report Number
    3004209178-2017-01582
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    February 1, 2016
    Report Date
    March 30, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377775, LOT# V011886, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# N0039786, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377775, LOT# V011886, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# N0039786, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT# V011886) FOUND THAT ALL CIRCUITS WERE OPEN. THERE WERE TITAN ANCHOR IMPRESSIONS 60.7 CM TO 61.2 CM FROM THE PROXIMAL END AND ALL CONDUCTORS WERE BROKEN 62.5 CM FROM THE PROXIMAL END. CONDUCTOR #0 WAS BROKEN IN THE ELECTRODE AREA AT 73.3 CM FROM THE PROXIMAL END. CONDUCTOR #1 WAS BROKEN AT 4.5 CM FROM THE DISTAL END DUE TO OVERSTRESS/DAMAGE. CONDUCTOR #2 WAS ALSO BROKEN IN THE ELECTRODE AREA AT 73.3 CM FROM THE PROXIMAL END WHICH WAS LOCATED AT THE ELECTRODE CRIMP SLEEVE. CONDUCTOR #3 WAS BROKEN 72.5 CM FROM THE PROXIMAL END AT THE ELECTRODE CRIMP SLEEVE. ANALYSIS OF THE LEAD (LOT# N0039786) FOUND THAT ALL CIRCUITS WERE OPEN. THERE WERE TITAN ANCHOR IMPRESSIONS 60.7 CM TO 61.2 CM FROM THE PROXIMAL END AND ALL CONDUCTORS WERE BROKEN AT 62.5 CM FROM THE PROXIMAL END. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS REPORTED REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS USED FOR SPINAL PAIN. MANUFACTURER REPRESENTATIVE REPORTED AFTER THE INS REPLACEMENT IN 2016, THE PATIENT FELT A SHOCKING SENSATION THROUGH THEIR BODY. THIS REPORTEDLY BEGAN IN (B)(6) 2016. IT WAS REPORTED THAT REPROGRAMMING WAS DONE AND THE PATIENT FELT FINE FOR A WHILE, GETTING THE COVERAGE THEY NEEDED, BUT OVER TIME THE COVERAGE HAD DECREASED. IMPEDANCES WERE DONE THE DAY OF THE REPORT. ELECTRODES 3 AND 4 WERE WITHIN NORMAL LIMITS AND THE REST WERE SHOWING GREATER THAN. THE EXACT VALUES WERE UNSURE. THE WORKING ELECTRODES WERE NOT ENOUGH TO COVER THE PATIENT'S PAIN AREA. A LEAD REVISION WAS REPORTED. IT WAS REPORTED THAT WHEN BOTH LEADS WERE EXPLANTED, ONE OF THE LEADS HAD A FRACTURE. THE LAST 3 ELECTRODES WERE DISCONNECTED. IT WAS REPORTED THAT THE PHYSICIAN REMOVED ALL CONTACTS AND THEY WERE ALL ACCOUNTED FOR. NO ELECTRODES WERE LEFT IN PATIENT'S BODY. IT WAS REPORTED THAT AFTER THE REVISION THE PATIENT HAD MUCH BETTER COVERAGE OVERALL THAN BEFORE. THE PATIENT WAS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LACK OF PARESTHESIA RESULTING IN A LACK OF PAIN RELIEF. IT WAS REPORTED THAT A NUMBER OF LEAD CONTACTS HAD OUT OF RANGE IMPEDANCES, WHICH LEAD TO THE PATIENT GETTING GOOD STIMULATION/RELIEF. THE LEADS WERE REPLACED ON (B)(6) 2017, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57917 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention